Sertraline

Sertraline is a prescription medicine used to treat depression, obsessive-compulsive disorder (OCD), panic disorders, posttraumatic stress disorder (PTSD), social anxiety disorder, and premenstrual dysphoric disorder (PMDD). It is sold under the brand name Zoloft, and generic sertraline is widely available.

Sertraline belongs to a group of medicines called selective serotonin reuptake inhibitors, or SSRIs. It increases serotonin activity in the brain by blocking the reuptake of serotonin (a chemical messenger that nerve cells use to communicate) back into nerve cells, so more of it stays available. Sertraline has only very weak effects on the reuptake of norepinephrine and dopamine, and it does not block monoamine oxidase.

Sertraline is available as tablets (25 mg, 50 mg, and 100 mg), oral solution (20 mg/mL), and capsules (150 mg and 200 mg).

Sertraline is not a controlled substance.

Sertraline is FDA-approved to treat six conditions in adults:

• Major depressive disorder (MDD), the clinical term for depression.
• Obsessive-compulsive disorder (OCD), where unwanted thoughts drive repeated behaviors.
• Panic disorder, which causes sudden attacks of intense fear along with physical symptoms.
• Posttraumatic stress disorder (PTSD), which can follow a frightening or traumatic event.
• Social anxiety disorder (SAD), also called social phobia.
• Premenstrual dysphoric disorder (PMDD), a severe form of premenstrual symptoms.

In children and teenagers, sertraline is approved only for OCD, from age 6 upward. Its safety and effectiveness have not been established in children under 6 years of age, or in children and teenagers for any condition other than OCD.

Not every sertraline product is approved for all six conditions:

• Sertraline tablets and oral solution are approved for all of them.
• Sertraline 150 mg and 200 mg capsules are approved only for depression in adults and for OCD in adults and children aged 6 and over.

Take sertraline exactly as prescribed, once a day, in either the morning or the evening. Take it at around the same time each day.

• Tablets and capsules can be taken with or without food. Taking sertraline with food causes only a small increase in the amount absorbed.
• Swallow capsules whole. Do not open, crush, or chew them.
• Your doctor may start you on a low dose and raise it gradually, usually no more often than once a week.
• Keep taking sertraline even if you feel well, and do not stop without talking to your doctor first.
• Tell any doctor or lab that you take sertraline before you have tests. Sertraline can cause a false-positive result on urine screening tests for benzodiazepines, and this can continue for several days after you stop taking it. A confirmatory test will tell the difference.
• Store sertraline at room temperature, 68°F to 77°F (20°C to 25°C).

How to take sertraline oral solution

Sertraline oral solution must be diluted before you take it. Do not mix it in advance.

• Use the dropper supplied with the bottle. The dropper has graduation marks for 25 mg and 50 mg only.
• Mix your dose with 4 ounces (half a cup) of water, ginger ale, lemon or lime soda, lemonade, or orange juice only. Do not mix it with any other liquid.
• Drink it straight away. A slight haze may appear after mixing, and this is normal.

The dropper dispenser contains dry natural rubber, a form of latex. Tell your doctor or pharmacist if you have a latex allergy.

Sertraline carries a boxed warning, the FDA's most serious type of warning. Antidepressants increased the risk of suicidal thoughts and behavior in children, teenagers, and young adults in short-term studies.

In pooled analyses of placebo-controlled antidepressant trials covering about 77,000 adults and more than 4,500 children and teenagers, the risk of suicidal thoughts and behaviors in people aged 24 and under was higher with an antidepressant than with placebo. The risk varied considerably between different antidepressants, and it also varied by condition, with the highest rate in people being treated for depression. The difference between antidepressant and placebo, per 1,000 patients treated, was:

It is not known whether this risk continues beyond about four months of treatment. There is good evidence that antidepressants delay depression coming back in adults, and depression itself raises the risk of suicidal thoughts and behaviors.

Anyone taking sertraline should be watched closely for worsening symptoms and for new or sudden changes in mood, behavior, thoughts, or feelings, especially in the first few months of treatment and whenever the dose is changed. Call your healthcare provider right away, or call 911 in an emergency, if you notice:

• thoughts about suicide or dying, or attempts to harm yourself
• new or worse depression, anxiety, or panic attacks
• feeling agitated, restless, angry, or irritable
• acting aggressive or violent, or acting on dangerous impulses
• trouble sleeping
• a big increase in activity or talking more than is normal for you
• any other unusual change in behavior or mood

Tell family members or caregivers which symptoms to watch for, so they can call your provider if you are not able to.

You should not take sertraline if you are allergic to sertraline or any of the ingredients in it, if you take an MAOI or have taken one in the past 14 days, or if you take pimozide. Do not take the oral solution if you take disulfiram.

To make sure sertraline is safe for you, tell your doctor if you have or have ever had:

• liver problems
• kidney problems
• heart problems, or risk factors for a heart rhythm problem called QTc prolongation
• bipolar disorder or mania
• seizures or convulsions
• low sodium levels in your blood
• bleeding problems, or you take a medicine that thins the blood
• narrow angles in the eye or glaucoma
• a stroke or high blood pressure

Pregnancy

Tell your doctor if you are pregnant, plan to become pregnant, or become pregnant while taking sertraline. Studies of women exposed to sertraline in the first trimester suggest no overall difference in the risk of major birth defects compared with the background rate. Some studies have reported increases in specific defects, but those results are inconclusive.

Taking sertraline late in pregnancy may raise the risk of newborn problems that need longer hospital stays, breathing support, and tube feeding, and of persistent pulmonary hypertension of the newborn (PPHN), a serious lung problem. Use in the month before delivery has been linked with a less than two-fold increase in the risk of postpartum hemorrhage (heavy bleeding after birth).

Stopping treatment is not automatically the safer choice. In one study of 201 pregnant women with a history of major depression, those who stopped their antidepressant during pregnancy were more likely to relapse than those who continued. This is a decision to make with your doctor.

Sertraline oral solution contains 12% alcohol and is not recommended during pregnancy, because there is no known safe level of alcohol exposure in pregnancy.

There is a pregnancy registry that collects information on antidepressant use in pregnancy. You can join by calling 1-866-961-2388.

Breastfeeding

Low levels of sertraline and its breakdown products pass into breast milk. In a pooled analysis of 53 mother and infant pairs, exclusively breastfed infants had an average of 2% of the sertraline levels measured in their mothers' blood, ranging from 0% to 15%. No side effects were seen in those infants. There is no information on whether sertraline affects milk production. Talk with your doctor about the benefits of breastfeeding alongside your need for treatment.

Children

Sertraline is approved for OCD in children aged 6 to 17 years. It is not known to be safe and effective in children under 6, or for any other condition in this age group. Children and teenagers taking sertraline should be monitored for worsening symptoms and suicidal thoughts, especially early in treatment and when the dose changes, and their weight and growth should be checked.

Older adults

Older adults clear sertraline more slowly. In one study, plasma clearance in people aged 65 and over was about 40% lower than in adults aged 25 to 32, so it took 2 to 3 weeks to reach steady levels rather than about 1 week. Doctors usually start older adults at the low end of the dose range. Older adults are also at greater risk of low sodium levels in the blood, particularly if they take diuretics (water pills) or are dehydrated.

Common sertraline side effects

The most common sertraline side effects are nausea, diarrhea or loose stools, trouble sleeping, dry mouth, tiredness, dizziness, sleepiness, tremor, indigestion, agitation, reduced appetite, increased sweating, and sexual problems.

The table below shows how often each side effect was reported in pooled placebo-controlled trials in 3,066 adults, compared with 2,293 people taking placebo.

Some side effects were more common with particular conditions. Sleepiness was more common in depression trials, insomnia and agitation in OCD trials, constipation and agitation in panic disorder trials, tiredness in PTSD trials, and insomnia, dizziness, tiredness, dry mouth, and a general feeling of being unwell in social anxiety disorder trials. In PMDD trials, sleepiness, dry mouth, dizziness, tiredness, and stomach pain were more common.

In these trials, 12% of people taking sertraline stopped treatment because of a side effect, compared with 4% of people taking placebo. The most common reasons for stopping were nausea (3%), diarrhea (2%), agitation (2%), and insomnia (2%).

Sexual side effects of sertraline

SSRIs including sertraline can cause sexual problems. In men, this can mean delayed ejaculation or being unable to ejaculate, lower sex drive, and difficulty getting or keeping an erection. In women, it can mean lower sex drive and delayed orgasm or being unable to have an orgasm.

Changes in sex drive and sexual function can also be part of depression and anxiety themselves, so the timing of when symptoms started matters. These numbers may underestimate how often sexual side effects happen, because people and their providers do not always raise the subject. Tell your provider about any change in sexual function, since there may be ways to manage it.

Serious sertraline side effects

Get emergency medical help if you have signs of an allergic reaction to sertraline: rash, hives, swelling of the face, lips, tongue, or throat, or difficulty breathing.

Call your doctor at once if you have:

• signs of serotonin syndrome, which can be life threatening: agitation, hallucinations, confusion, coma or other changes in mental state, a racing heartbeat, high or low blood pressure, dizziness, heavy sweating, fever, muscle stiffness, twitching or overactive reflexes, loss of coordination, seizures, nausea, vomiting, or diarrhea;
• unusual bleeding or bruising, including nosebleeds, bleeding gums, blood in vomit or stools, or black tarry stools;
• signs of a manic episode: greatly increased energy, severe trouble sleeping, racing thoughts, reckless behavior, unusually grand ideas, excessive happiness or irritability, or talking more or faster than usual;
• seizures or convulsions;
• eye pain, changes in vision, or swelling or redness in or around the eye, which can be signs of angle-closure glaucoma (a sudden rise in pressure inside the eye);
• signs of low sodium in the blood (hyponatremia): headache, trouble concentrating or thinking, memory problems, confusion, weakness, or feeling unsteady, which can lead to falls. Severe cases have caused hallucinations, fainting, seizures, coma, and death;
• fainting, chest discomfort, or an irregular heartbeat, which can be signs of a heart rhythm problem called QTc prolongation.

Sertraline side effects in children and teenagers

The overall pattern of side effects in 281 children and teenagers treated with sertraline was generally similar to that seen in adults. Side effects reported in at least 2% of children and teenagers, and at least twice as often as with placebo, that were not common in adults were fever, hyperkinesia (abnormally increased movement), urinary incontinence, aggression, nosebleeds, purpura (purple spots under the skin), joint pain, weight loss, muscle twitching, and anxiety.

Reduced appetite and weight loss have been seen with SSRIs, so height and weight should be monitored during treatment.

Other reported side effects

Less common side effects reported during studies include tachycardia (fast heartbeat), tinnitus (ringing in the ears), underactive thyroid, enlarged pupils, blurred vision, blood in the stools, swelling, unsteady walking, irritability, fever, raised liver enzymes, anaphylaxis, diabetes, high cholesterol, low blood sugar, increased appetite, joint pain, muscle spasms, poor coordination, coma, convulsions, reduced alertness, numbness, lethargy, restlessness, fainting, aggression, teeth grinding, confusion, euphoric mood, hallucination, blood in the urine, milk production from the breasts, priapism (a long-lasting erection), vaginal bleeding, wheezing, yawning, hair loss, cold sweats, skin inflammation, blistering, itching, rash, hives, bleeding, high blood pressure, and flushing.

Side effects reported after sertraline came onto the market include increased clotting times, AV block, slow heartbeat, atrial arrhythmias, QTc prolongation, ventricular tachycardia including Torsade de Pointes, breast enlargement in men, raised prolactin, irregular periods, SIADH, blindness, optic neuritis, cataract, severe liver problems including hepatitis, jaundice, and liver failure with some fatal outcomes, pancreatitis, several blood disorders, angioedema, low sodium, high blood sugar, rhabdomyolysis (muscle breakdown), lockjaw, serotonin syndrome, movement disorders including akathisia and dystonia, psychosis, bedwetting, nightmares, sudden kidney failure, pulmonary hypertension, eosinophilic pneumonia, loss of smell, photosensitivity, severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, spasm of blood vessels in the brain, and vasculitis.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Do not take sertraline with a monoamine oxidase inhibitor (MAOI), or within 14 days of stopping one, because of the risk of serotonin syndrome. This includes the antibiotic linezolid and intravenous methylene blue. You also need to wait at least 14 days after stopping sertraline before starting an MAOI.

Do not take sertraline with pimozide, an antipsychotic medicine. Do not take sertraline oral solution if you take disulfiram (Antabuse), because the solution contains alcohol.

Sertraline can raise the risk of bleeding, particularly if you also take aspirin, NSAIDs such as ibuprofen or naproxen, other antiplatelet medicines, warfarin, or other anticoagulants.

Screening for a personal or family history of bipolar disorder, mania, or hypomania is recommended before starting sertraline, since treating a depressive episode with an antidepressant can trigger a manic episode in someone with bipolar disorder.

Do not stop taking sertraline suddenly. Adverse reactions can occur when it is stopped, especially when it is stopped abruptly, so the dose should be lowered gradually where possible.

The usual starting dose of sertraline is 25 mg or 50 mg once a day, depending on the condition being treated, and the usual treatment range is 50 mg to 200 mg a day. The maximum dose for most conditions is 200 mg a day.

If the starting dose is not enough, the dose can be raised in steps of 25 mg to 50 mg a day. Because sertraline stays in the body for about 24 hours, doses are usually changed no more often than once a week.

Dosing for PMDD. Sertraline can be taken every day of the menstrual cycle, or only during the luteal phase, meaning you start 14 days before your period is due and continue until it starts, then repeat with each cycle. On daily dosing, the dose can go up by 50 mg per cycle to a maximum of 150 mg a day. On luteal phase dosing, the maximum is 100 mg a day, taken as 50 mg for the first 3 days of the dosing cycle and 100 mg for the rest of it.

Sertraline 150 mg and 200 mg capsules. These are not used to start treatment or to titrate a dose, because there are no lower capsule strengths. They can be started in someone who has been taking 100 mg or 125 mg of another sertraline product for at least a week. The recommended capsule dose is 150 mg or 200 mg once a day, and the maximum is 200 mg a day. Because the dose cannot be lowered in steps using capsules alone, coming off treatment requires switching back to another sertraline product.

Liver problems. With sertraline tablets and oral solution, mild liver impairment (Child-Pugh score 5 or 6) means both the starting dose and the usual range are halved, and use is not recommended in moderate or severe liver impairment (Child-Pugh score 7 to 15). Sertraline capsules are not recommended in mild, moderate, or severe liver impairment, because the dose cannot be adjusted with the strengths available.

Kidney problems. No dose change is needed for mild, moderate, or severe kidney impairment, including in people on dialysis.

• Sertraline 25 mg tablets
• Sertraline 50 mg tablets
• Sertraline 100 mg tablets
• Sertraline oral solution, 20 mg per mL
• Sertraline 150 mg capsules
• Sertraline 200 mg capsules

Capsule strengths are based on sertraline itself. A 150 mg capsule contains 168 mg of sertraline hydrochloride, and a 200 mg capsule contains 224 mg. Capsule appearance and imprints differ between manufacturers.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the one you missed and take the next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Effects reported after a sertraline tablet overdose include seizures, which may be delayed, and changes in mental state including coma. Heart effects can also be delayed and include changes in the electrical activity of the heart (QRS and QTc prolongation). High blood pressure is seen most often, and low blood pressure is rare, though it can happen when other substances including alcohol have also been taken. Serotonin syndrome can occur, and the risk is higher when several drugs that raise serotonin have been taken together.

• Do not drink alcohol while you take sertraline. In healthy volunteers, sertraline did not add to the immediate effects of alcohol on thinking and coordination, but drinking is still not recommended during treatment.
• Do not drive or operate machinery until you know how sertraline affects you. It can cause sleepiness and can affect your ability to think clearly, make decisions, or react quickly.
• Do not start or stop any other medicine without checking first, including over-the-counter products, vitamins, and herbal supplements.

Several medicines interact with sertraline. Give a full list of everything you take to any provider who treats you. The most important interactions are:

• MAOIs. Taking sertraline with an MAOI raises the risk of serotonin syndrome, and the combination is contraindicated. Examples include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, and methylene blue.
• Pimozide. Sertraline raises pimozide levels, which can lead to QTc prolongation and irregular heartbeats. The combination is contraindicated.
• Other medicines that raise serotonin. These add to the risk of serotonin syndrome. Examples include other SSRIs and SNRIs, triptans for migraine, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John's wort.
• Blood thinners and antiplatelet medicines. Aspirin, clopidogrel, heparin, and warfarin can add to the bleeding risk. If you take warfarin, your INR should be monitored carefully.
• Medicines broken down by CYP2D6. Sertraline blocks this liver enzyme, so levels of these drugs can rise and doses may need to be lowered. Examples include propafenone, flecainide, atomoxetine, desipramine, dextromethorphan, metoprolol, nebivolol, perphenazine, thioridazine, tolterodine, and venlafaxine.
• Phenytoin and fosphenytoin. Sertraline can raise phenytoin levels, so levels should be checked when sertraline is started or the dose is changed.
• Medicines that prolong the QTc interval. These should generally be avoided. Examples include certain antipsychotics (ziprasidone, iloperidone, chlorpromazine, mesoridazine, droperidol), certain antibiotics (erythromycin, gatifloxacin, moxifloxacin, sparfloxacin), Class 1A antiarrhythmics (quinidine, procainamide), Class III antiarrhythmics (amiodarone, sotalol), and others including pentamidine, methadone, halofantrine, mefloquine, dolasetron, probucol, and tacrolimus.
• Disulfiram, with the oral solution only, because of its alcohol content.

No dose adjustment is needed when sertraline is taken with cimetidine, diazepam, lithium, atenolol, tolbutamide, digoxin, or medicines broken down by CYP3A4.

This list is not complete. Many other prescription medicines, over-the-counter products, vitamins, and herbal products can interact with sertraline.